2023
1184-P: No Increased Risk of Gestational Diabetes Mellitus (GDM) Diagnosis after COVID-19 Vaccination
VESCO K, DENOBLE A, LIPKIND H, KHARBANDA E, DESILVA M, DALEY M, GETAHUN D, ZERBO O, NALEWAY A, JACKSON L, WILLIAMS J, BOYCE T, FULLER C, VAZQUEZ BENITEZ G. 1184-P: No Increased Risk of Gestational Diabetes Mellitus (GDM) Diagnosis after COVID-19 Vaccination. Diabetes 2023, 72 DOI: 10.2337/db23-1184-p.Peer-Reviewed Original ResearchCOVID-19 vaccinationCOVID-19 vaccineRisk of GDMCOVID-19 vaccine dosesNon-Hispanic whitesGDM diagnosisVaccine dosesDisease controlGestational diabetes mellitus diagnosisDe novo diabetesRate of GDMDiagnosis of GDMVaccine Safety DatalinkPfizer Inc.Confidence intervalsICD-10 codesNon-Hispanic blacksDiabetes mellitus diagnosisOutcomes Research InstituteNon-Hispanic AsiansHealth care systemNonpregnant adultsUnvaccinated individualsIncreased riskRelative riskReport of the first seven agents in the I-SPY COVID trial: a phase 2, open label, adaptive platform randomised controlled trial
Consortium T, Files D, Aggarwal N, Albertson T, Auld S, Beitler J, Berger P, Burnham E, Calfee C, Cobb N, Crippa A, Discacciati A, Eklund M, Esserman L, Friedman E, Gandotra S, Khan K, Koff J, Kumar S, Liu K, Martin T, Matthay M, Meyer N, Obermiller T, Robinson P, Russell D, Thomas K, Wong F, Wunderink R, Wurfel M, Yen A, Youssef F, Darmanian A, Dzierba A, Garcia I, Gosek K, Madahar P, Mittel A, Muir J, Rosen A, Schicchi J, Serra A, Wahab R, Gibbs K, Landreth L, LaRose M, Parks L, Wynn A, Ittner C, Mangalmurti N, Reilly J, Harris D, Methukupally A, Patel S, Boerger L, Kazianis J, Higgins C, McKeehan J, Daniel B, Fields S, Hurst-Hopf J, Jauregui A, Swigart L, Blevins D, Nguyen C, Suarez A, Tanios M, Sarafian F, Shah U, Adelman M, Creel-Bulos C, Detelich J, Harris G, Nugent K, Spainhour C, Yang P, Haczku A, Hardy E, Harper R, Morrissey B, Sandrock C, Budinger G, Donnelly H, Singer B, Moskowitz A, Coleman M, Levitt J, Lu R, Henderson P, Asare A, Dunn I, Barragan A. Report of the first seven agents in the I-SPY COVID trial: a phase 2, open label, adaptive platform randomised controlled trial. EClinicalMedicine 2023, 58: 101889. PMID: 36883141, PMCID: PMC9981330, DOI: 10.1016/j.eclinm.2023.101889.Peer-Reviewed Original ResearchInvestigational agentsSevere COVID-19Hazard ratioModified intention-to-treat analysisEvaluating investigational agentsRegimen of dexamethasoneIntention-to-treat analysisBackbone regimensOpen-labelDornase alfaEfficacy signalsScreening of agentsScreening potential therapeuticsData monitoring committeeHigh morbidityAdaptive platform trialCOVID trialsMedical CentrePfizer Inc.Controlled TrialsHospitalised patientsI-SPYPre-specified criteriaFast GrantTime-to-recovery
2022
864-P: Glycemic Control across eGFR Categories with the Dual SGLT1 and 2 Inhibitor Sotagliflozin in SCORED
INZUCCHI S, BHATT D, PITT B, SZAREK M, CANNON C, LEWIS J, RIDDLE M, KOSIBOROD M, CHERNEY D, DWYER J, SCIRICA B, BAILEY C, BANKS P, DIAZ R, RAY K, UDELL J, LOPES R, LEITER L, STEG P. 864-P: Glycemic Control across eGFR Categories with the Dual SGLT1 and 2 Inhibitor Sotagliflozin in SCORED. Diabetes 2022, 71 DOI: 10.2337/db22-864-p.Peer-Reviewed Original ResearchGlucose-lowering medicationsPre-specified subgroupsNovartis Pharmaceuticals CorporationGlaxoSmithKline plcDaiichi SankyoDual SGLT1Baseline A1CBaseline eGFRPfizer Inc.Bristol-Myers Squibb CompanyLexicon PharmaceuticalsOutcome trialsCSL BehringNovo NordiskNovartis AGAdvanced chronic kidney diseaseType 2 diabetes patientsEli LillyAmgen Inc.Lower baseline eGFROverall trial populationCKD stage 4Primary composite outcomeSpeakers bureauCardiovascular outcome trials
2020
271-OR: ADA Presidents’ Select Abstract: Effect of Dapagliflozin on the Incidence of Diabetes: A Prespecified Exploratory Analysis from DAPA-HF
INZUCCHI S, DOCHERTY K, KOBER L, KOSIBOROD M, MARTINEZ F, PONIKOWSKI P, SABATINE M, SOLOMON S, BELOHLAVEK J, BÖHM M, CHIANG C, DE BOER R, DIEZ M, DUKAT A, LJUNGMAN C, VERMA S, DEMETS D, BENGTSSON O, LANGKILDE A, SJÖSTRAND M, JHUND P, MCMURRAY J. 271-OR: ADA Presidents’ Select Abstract: Effect of Dapagliflozin on the Incidence of Diabetes: A Prespecified Exploratory Analysis from DAPA-HF. Diabetes 2020, 69 DOI: 10.2337/db20-271-or.Peer-Reviewed Original ResearchNovartis Pharmaceuticals CorporationBoehringer Ingelheim PharmaceuticalsBristol-Myers SquibbIncidence of diabetesNovo Nordisk A/SHeart failureJanssen PharmaceuticalsNovartis AGDAPA-HFEisai Inc.Incident T2DSpeakers bureauEli LillyGlaxoSmithKline plcCox proportional hazards modelDaiichi SankyoBenefit of dapagliflozinNew-onset T2DPrespecified exploratory analysisSGLT2 inhibitor dapagliflozinNew-onset diabetesAdvisory PanelEffect of dapagliflozinPfizer Inc.Janssen Scientific Affairs
2019
19-LB: Consistent Cardiovascular (CV) Benefits from Empagliflozin across the Spectrum of CV Risk Factor Control: Post Hoc Analysis from EMPA-REG OUTCOME
INZUCCHI S, KHUNTI K, FITCHETT D, WANNER C, MATTHEUS M, GEORGE J, PERNILLE OFSTAD A, ZINMAN B. 19-LB: Consistent Cardiovascular (CV) Benefits from Empagliflozin across the Spectrum of CV Risk Factor Control: Post Hoc Analysis from EMPA-REG OUTCOME. Diabetes 2019, 68 DOI: 10.2337/db19-19-lb.Peer-Reviewed Original ResearchRisk factor goalsCV deathDohme Corp.Boehringer Ingelheim PharmaceuticalsNovo Nordisk A/SJanssen PharmaceuticalsMerck SharpTakeda Pharmaceutical Company LimitedHazard ratioRisk factorsNovartis AGEli LillyACE inhibitor/ARB useCV risk factor controlConsistent cardiovascular benefitEMPA-REG OUTCOMECV risk factorsRisk factor controlPfizer Inc.Sanofi-AventisNon-smoking statusAdvisory PanelPost Hoc AnalysisCV risk increasesARB use
2018
Empagliflozin (EMPA) Reduces Mortality and Hospitalization for Heart Failure (HHF) Irrespective of Cardiovascular (CV) Risk Score at Baseline
FITCHETT D, SCIRICA B, INZUCCHI S, CANNON C, MCGUIRE D, JOHANSEN O, SAMBEVSKI S, HEHNKE U, GEORGE J, ZINMAN B. Empagliflozin (EMPA) Reduces Mortality and Hospitalization for Heart Failure (HHF) Irrespective of Cardiovascular (CV) Risk Score at Baseline. Diabetes 2018, 67 DOI: 10.2337/db18-1123-p.Peer-Reviewed Original ResearchEMPA-REG OUTCOME trialBoehringer Ingelheim PharmaceuticalsBaseline CV riskCV deathProportion of patientsCause deathEisai Inc.CV riskOutcome trialsRisk scoreJanssen PharmaceuticalsGlaxoSmithKline plcBristol-Myers Squibb CompanyNovo Nordisk A/SLexicon PharmaceuticalsEli LillyBenefits of empagliflozinBoehringer Ingelheim GmbHResidual CV riskEffect of empagliflozinTIMI risk scorePfizer Inc.Sanofi-AventisCardiovascular risk scoreAmgen Inc.
2017
Surgical Experience in Two Multicenter, Open-Label Phase 3 Studies of Emicizumab in Persons with Hemophilia A with Inhibitors (HAVEN 1 and HAVEN 2)
Kruse-Jarres R, Callaghan M, Croteau S, Jimenez-Yuste V, Khoo L, Liesner R, Matsushita T, Recht M, Young G, Chang T, Dhalluin C, Mu Y, Xu J, Devenport J, Ko R, Solari P, Oldenburg J. Surgical Experience in Two Multicenter, Open-Label Phase 3 Studies of Emicizumab in Persons with Hemophilia A with Inhibitors (HAVEN 1 and HAVEN 2). Blood 2017, 130: 89. DOI: 10.1182/blood.v130.suppl_1.89.89.Peer-Reviewed Original ResearchPost-operative bleeding eventsPost-operative bleedingEntity's Board of DirectorsOpen-label phase 3 studyTooth extractionBleeding eventsHAVEN 1Surgical proceduresCSL BehringTreated with BPAInterim analysisHAVEN 2Hemophilia AFrequency of post-operative bleedingSurgical experienceClinical studiesHemophilia A with inhibitorsKnee arthroscopyInvestigational clinical studyPfizer Inc.Treated with emicizumabPre-operative treatmentPhase 3 studyPrevention of bleedingAnalysis of patients
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